The data on hazard and risk are based on previous environmental information on fass.se. Environmental information is missing (2021-09-10). It is voluntary for manufacturers to provide information about environmental impact on fass.se. Clotrimazole is monitored within the framework of EU water legislation.
Persistence. Clotrimazole is potentially persistent.
Bioaccumulation. Clotrimazole has high potential for bioaccumulation.
Toxicity. Clotrimazole has high chronic toxicity.
Risk. The use of clotrimazole (sales data Sweden 2011) has been considered to result in insignificant environmental risk.
Fass environmental information
Fass environmental information for Canesten (clotrimazole) (downloaded 2013-06-25).
Persistence: "CO2 evolution test, guideline, C.4 C (6)). Test results 0% degradation in 28 days (guideline 79/831/EEC)."
Bioaccumulation: "Log Pow 4.1 (EU guideline 92/69/EC, A.8). Since log Pow 4.1, the substance has high potential for bioaccumulation."
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for crustacean (Dapnia magna) 10 microg/L.
clotrimazole is not PBT/vPvB.
PEC/PNEC is based on sales data in Sweden in year 2011. PEC/PNEC = 0.013 which gives the risk insignificant.
Pharmaceutical analyses of water in Stockholm County
Clotrimazole has been detected in treated wastewater and surface water in Region Stockholm.
Report Pharmaceutial residues in the Stockholm aquatic environment
Clotrimazole has been detected in incoming and outgoing water from Swedish wastewater treatment plants.
EU water legislation
Clotrimazole is monitored within the framework of EU water legislation. "Substances for which doubt exists about their toxicity, or for which the sensitivity, reliability or comparability of the available monitoring methods are not adequate, should not be included in the watch list. The sulfonamide antibiotic sulfamethoxazole and the diaminopyrimidine antibiotic trimethoprim, the antidepressant venlafaxine and its metabolite O-desmethylvenlafaxine, a group of three azole pharmaceuticals (clotrimazole, fluconazole and miconazole) ... The inclusion of the various pharmaceuticals is consistent with the EU Strategic Approach to Pharmaceuticals in the Environment, and the inclusion of the two antibiotics is also consistent with the European One Health Action Plan against Antimicrobial Resistance (AMR), which supports the use of the watch list to ‘improve knowledge of the occurrence and spread of antimicrobials in the environment’."
- SLL. Sammanställning av läkemedelsprovtagningar - Bearbetning av regional försäljningsstatistik av läkemedel samt datamaterial från Stockholms läns landstings mätprogram för läkemedelssubstanser i vattenmiljö, 2012–2016.
- Stockholm Vatten. Läkemedelsrester i Stockholms vattenmiljö. 2010. ISBN 978-91-633-6642-0.
- Official Journal of the European Union. Commission implementing decision (EU) 2020/1161 of 4 August 2020.
- Official Journal of the European Union. Commission implementing decision (EU) 2022/1307 of 22 July 2022.
Author: Health and Medical Care Administration, Region Stockholm